510(k) · Cleared
ClearedNC Euphora Rapid Exchange Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Aug 15, 2014 as substantially equivalent to P790017 (Medtronic, Ireland, 1980) after a 109-day review. Its family tree reaches back 1 generation to 1980. 2 later devices descend from it.
- Decided
- Aug 15, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P790017 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- This deviceK141090 NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK261428 NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic Ireland · 2026
- Descendant · cites it directly · 0 of its ownK212393 OPN NC PTCA Dilatation CatheterSis Medical AG · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| 0 (this device) | K141090 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic, Inc. | 2014 | — |
| +1 | K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | 2026 | — |
| +1 | K212393 | OPN NC PTCA Dilatation Catheter | Sis Medical AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P790017 | Usci Dilatation CatheterSummary page 5…respect to intended use, Device: design and technology: Medtronic NC Sprinter® RX Balloon Dilatation Catheter (P790017/S095, approved October 10, 2008) Summary of The EuphoraTM RX Balloon Dilatation Catheter represents a Technological s… | 1980 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
MAUDE reports naming product code LOX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
What is it indicated for?
The NC Euphora™ Rapid Exchange Balloon Dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable stents.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141090: NC Euphora Rapid Exchange Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141090
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026